作者
Caicun Zhou,Yanping Hu,Ekaterine Arkania,Saadettin Kılıçkap,Kejing Ying,Fei Xu,Lin Wu,Xiang Wang,Maksym Viguro,Tamta Makharadze,Hongmei Sun,Feng Luo,Jianhua Shi,Aimin Zang,Yueyin Pan,Zhendong Chen,Zhongyao Jia,Vladimer Kuchava,Ping Lu,Ling Zhang,Ying Cheng,Wanying Kang,Li Wang,Haoyu Yu,Jing Li,Junwu Zhu
摘要
Combining immunotherapy with chemotherapy can provide improved survival in advanced squamous non-small-cell lung cancer (NSCLC) patients without targetable gene alterations. 537 previously untreated patients with stage IIIB/IIIC or IV squamous NSCLC without targetable gene alterations were enrolled and randomized (2:1) to receive serplulimab 4.5 mg/kg or placebo, both in combination with nab-paclitaxel and carboplatin, intravenously in 3-week cycles. The primary endpoint of progression-free survival (PFS) was met at the first interim analysis. At the second interim analysis, PFS benefit was maintained in serplulimab-chemotherapy group (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.42–0.67). At the final analysis, serplulimab-chemotherapy significantly improved median OS compared to placebo-chemotherapy (HR 0.73, 95% CI 0.58–0.93; p = 0.010). Grade ≥3 serplulimab or placebo-related adverse events occurred in 126 (35.2%) and 58 (32.4%) patients, respectively. Our results demonstrate that adding serplulimab to chemotherapy significantly improves survival in advanced squamous NSCLC patients, with manageable safety.